LEISH-PED: Study on Leishmaniasis in Children (LEISH-PED)

A Multicenter Study on Leishmaniasis in Children: Clinical and Epidemiological Characteristics and Outcomes

Leishmaniasis is an infection caused by Leishmania parasites. In children, it can affect the skin or internal organs. Diagnosis may be delayed because the signs and symptoms can be similar to those of other conditions. Delayed diagnosis or treatment may lead to worse outcomes. Treatment approaches, especially for cutaneous leishmaniasis, may also vary across centers. This study aims to improve knowledge about pediatric leishmaniasis in Italy.

This is a multicenter observational study in children younger than 18 years of age with a diagnosis of human leishmaniasis according to World Health Organization criteria. The study includes both retrospective and prospective data from participating centers in Italy. Researchers will collect and analyze clinical, diagnostic, epidemiological, treatment, and outcome data from the baseline visit and from follow-up during the first year.

The main goal of the study is to describe the clinical and epidemiological features of pediatric leishmaniasis in Italy over the study period, with a particular focus on diagnostic and treatment delay and on patient outcomes. The study will also assess the frequency and severity of disease over time and compare outcomes associated with different treatment approaches, particularly in cutaneous leishmaniasis. Patients evaluated between January 1, 2013 and June 30, 2031 may be included.

Study Overview

• Status: Recruiting
• Conditions: Leishmaniasis, Cutaneous; Leishmaniasis, Visceral; Leishmaniasis, Mucocutaneous; Leishmania Infantum Disease

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Elisabetta Venturini, MD,Phd; Phone Number: +39 3490920901; Email: elisabetta.venturini@meyer.it

Study Locations

• Italy
  • Tuscany
    • Florence, Tuscany, Italy, 50139
      • Recruiting
      • AOU Meyer IRCCS
      • Contact: Elisabetta Venturini, MD, PhD; Phone Number: +39 3490920901; Email: elisabetta.venturini@meyer.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents younger than 18 years of age with confirmed human leishmaniasis (visceral, cutaneous, or mucocutaneous) diagnosed according to WHO criteria and evaluated as inpatients or outpatients at participating Italian pediatric centers during the study period. Both retrospectively and prospectively identified patients may be included.

Description

Inclusion Criteria:

• Patients younger than 18 years of age at the time of diagnosis
• Diagnosis of human leishmaniasis according to World Health Organization (WHO) criteria
• Written informed consent signed by parents or legal guardians; patient assent when applicable

Exclusion Criteria:

• Patients who do not meet the diagnostic criteria for confirmed human leishmaniasis
• Lack of informed consent signed by parents or legal guardians, when required

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Visceral Leishmaniasis; Children younger than 18 years of age with confirmed visceral leishmaniasis, diagnosed according to World Health Organization criteria, evaluated at participating centers during the study period. Retrospective and prospective clinical, diagnostic, treatment, and outcome data will be collected.
Cutaneous Leishmaniasis; Children younger than 18 years of age with confirmed cutaneous leishmaniasis, diagnosed according to World Health Organization criteria, evaluated at participating centers during the study period. Retrospective and prospective clinical, diagnostic, treatment, and outcome data will be collected, including assessment of different treatment approaches and healing outcomes.
Mucocutaneous Leishmaniasis; Children younger than 18 years of age with confirmed mucocutaneous leishmaniasis, diagnosed according to World Health Organization criteria, evaluated at participating centers during the study period. Retrospective and prospective clinical, diagnostic, treatment, and outcome data will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery rate according to therapeutic and diagnostic delay	Association between recovery rate and diagnostic and therapeutic delay, based on the time intervals from symptom onset to diagnosis and from diagnosis to treatment initiation.	At diagnosis, 3, 6, 12 months from diagnosis
Death rate according to therapeutic and diagnostic delay	Association between death rate and diagnostic and therapeutic delay, based on the time intervals from symptom onset to diagnosis and from diagnosis to treatment initiation.	At diagnosis, 3, 6, 12 months from diagnosis
Relapse rate according to therapeutic and diagnostic delay	Association between relapse rate and diagnostic and therapeutic delay, based on the time intervals from symptom onset to diagnosis and from diagnosis to treatment initiation.	At diagnosis, 3, 6, 12 months from diagnosis
Severity of pediatric leishmaniasis	Severity of disease at presentation. For visceral leishmaniasis, severity will be assessed using duration of fever, hematologic abnormalities/cytopenias, duration of hospitalization, and occurrence of complications such as macrophage activation syndrome. For cutaneous and mucocutaneous leishmaniasis, severity will be assessed according to number and size of lesions and classification as simple or complicated forms.	At diagnosis, 3, 6, 12 months from diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for complicated forms of leishmaniasis	Association of age, area of origin, Leishmania species typing when available, and other clinical characteristics with the development of complicated visceral, cutaneous, or mucocutaneous leishmaniasis.	From January 1, 2013 to June 30, 2026
Risk factors for relapse of leishmaniasis	Association of demographic, microbiologic, and clinical factors with relapse after initial clinical improvement.	Baseline through 12 months of follow-up.

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): December 30, 2031

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Children; Diagnostic delay; Italy; Cutaneous leishmaniasis; Visceral leishmaniasis; Leishmania infantum; Pediatric leishmaniasis; Mucocutaneous leishmaniasis
• Additional Relevant MeSH Terms: Vector Borne Diseases; Infections; Protozoan Infections; Parasitic Diseases; Skin Diseases; Skin Diseases, Infectious; Skin Diseases, Parasitic; Euglenozoa Infections; Skin and Connective Tissue Diseases; Leishmaniasis; Leishmaniasis, Visceral; Leishmaniasis, Cutaneous; Leishmaniasis, Mucocutaneous
• Other Study ID Numbers: LEISH-PED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No